COVID19: Over 40000 People Will Participate In Russian Sputnik V Vaccine
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Russian researchers from Gamaleya National Research Institute of Epidemiology and Microbiology have announced today that next week more than 40,000 people in 45 medical centers will participate in a randomized, double-blind, placebo-controlled multicenter clinical study of the efficacy, immunogenicity and safety of the Sputnik V vaccine which will begin in Russia, simultaneously with the vaccination of volunteers from risk groups.
Phase 1 and 2 clinical trials of the vaccine have been completed on August 1, 2020. All the volunteers are feeling well, no unforeseen or unwanted side effects were observed. The vaccine induced strong antibody and cellular immune response. Not a single participant of the current clinical trials got infected with COVID-19 after being administered with the vaccine.
The high efficacy of the vaccine was confirmed by high precision tests for antibodies in the blood serum of volunteers (including an analysis for antibodies that neutralize the coronavirus), as well as the ability of the immune cells of the volunteers to activate in response to the spike S protein of the coronavirus, which indicates the formation of both antibody and cellular immune vaccine response.
Phase 3 clinical trial involving more than 2,000 people in Russia, a number of Middle Eastern (UAE and Saudi Arabia), and Latin American countries (Brazil and Mexico) started on August 12. The vaccine has received a registration certificate from the Russian Ministry of Health on August 11 and under emergency rules adopted during the COVID-19 pandemic can be used to vaccinate the population in Russia. Mass production of the vaccine is expected to start in September 2020.
According to Kirill Dmitriev, CEO of Russian Direct Investment Fund (RDIF), the Russian government is in contact with India for the production of the vaccine as they believe that India has the capacity to meet their huge demand of the production of this vaccine. Russian government has already received the demand of the doses of 1 Million Sputnik V vaccine from various countries.
Dmitriev said, “We get a lot of questions about the vaccine, including the platform on which it was developed. RDIF and the Gamaleya Institute strive for maximum transparency about the details of the vaccine’s development, which is why we post all information about adenovirus vaccines at sputnikvaccine. We would like to thank everyone for their interest in “Sputnik V” both in Russia and abroad – the vaccine website has already been visited by representatives of more than 200 countries.”
About The Sputnik V Vaccine:
Sputnik V is a first registered vaccine for COVID-19 as claimed by Russian researchers which is a human adenoviral vector vaccine. Adenoviruses (Ad) represent a promising vector platform for the development of vaccines for infectious disease, largely due to their safety and ability to stimulate robust cellular and/or humoral immune responses in multiple species as compared with other genetic vaccine platforms.
Key Facts About Human Adenovirus:
- Research on human adenoviruses as a potential base for vaccine development began in 1953.
- Vaccines do not contain live human adenoviruses, but human adenovirus vectors, that is, human viruses that cannot multiply in the body and are completely safe.
- More than 20,000 people have taken part in clinical trials of vaccines and drugs based on human adenoviruses or human adenoviral vectors.
- Human adenovirus vaccines have been used most widely by the US Army since 1971 to date. These type of vaccines are offered by the US Armed Forces to recruits. US Food and Drug Administration (FDA) approved human adenovirus vaccines in 2011. More than 10 million US military personnel have received the human adenovirus vaccines.
- An anti-cancer drug based on human adenoviral vectors has been used to treat more than 30,000 patients in China.
- Human adenovirus vaccines proven to have no long-term health risks, including no risk of carcinogenicity and no risk of affecting fertility. Health safety has been proven by more than 75 international publications and in more than 250 clinical trials.
- Other means of delivering viral genetic material to stimulate the body’s immune response, such as monkey adenovirus or mRNA technology, have never been used in approved vaccines before. No long-term studies have been conducted on the possible effects of such technologies for human body, including the possibility of cancer and the effect on fertility.
- The approach of the Gamaleya Institute with the vaccine using two human adenoviruses serotypes: number 5 (Ad5) and number 26 (Ad26) has a clear advantage over the one-vector approach used by other developers.
- Human adenoviral vectors are used in the development of vaccines against coronavirus by the world’s leading pharmaceutical companies. At the same time, their vaccines are single-vector: CanSino (China) uses the Ad5 vector, which has already been approved for use by the Chinese army, Johnson & Johnson (USA) uses the Ad26 vector. Johnson & Johnson has received orders for more than 140 million doses of the drug based on the vector Ad26 from the United States and Europe.